efficacy & safety of prophylaxis with bemiparin in cancer patients with a central venous catheter (becat)

Conditions: Cancer; Thrombosis

Summary: the purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of bemiparin (3,500 ui/day) in cancer patients with a cvc, to prevent cvc-related deep venous thrombosis (cvc-dvt)

venous thromboembolism (vte) is a common complication in patients with cancer principally in association with central vein catheters (cvc). the clinical benefit of antithrombotic prophylaxis for cvc-related vte in cancer patients remains unclear.the aim of this study is to evaluate the efficacy and safety of the administration of bemiparin in cancer patients with a central venous catheter (cvc). this study is designed as a multicenter, randomized, double-blind, placebo-controlled study. on the day of cvc insertion, eligible patients are randomly assigned to receive subcutaneously either bemiparin (3,500 ui/day) or placebo by using preloaded syringes for 45 days. the primary efficacy endpoint will be the combined incidence during the double blind treatment period of clinical or symptomatic cvc-dvt verified objectively (doppler ultrasonography or phlebography)and subclinical or asymptomatic cvc-dvt confirmed by elective bilateral doppler ultrasonography performed 45±5 days after randomization.

Eligibility criteria:
inclusion criteria: * patients over 18 years old of either sex who have given their informed consent to participate in the study. * patients with a neoplastic process, with a cvc for the administration of anti-tumoral treatment or any other treatment related to the neoplastic process. * patients with a platelet count above 30,000/mm3. * patients with no hemorrhagic symptomatology at the time of their inclusion exclusion criteria: * patients with a history of clinically evident hemorrhagic episodes and/or with increased bleeding due to any other homeostatic alteration that contraindicates anticoagulant treatment and/or in the past two months have presented at least one of the following: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms). * major surgery in the past two months. * known hypersensitivity to lmwh, heparin or substances of porcine origin. * patients with congenital or acquired bleeding diathesis. * damage to or surgical interventions of the central nervous system, eyes and ears within the past 6 months. * acute bacterial endocarditis or slow endocarditis. * patients with a history of heparin-associated thrombocytopenia. * patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic insufficiency (with values of ast and/or alt \> 5 times the normal value established by the reference range of the local hospital laboratory). * severe arterial hypertension (systolic blood pressure over 200 mmhg and/or diastolic blood pressure over 120 mmhg). * patients with suspected inability/or inability to comply with treatment and/or complete the study. * patients who are participating in another clinical trial or have done so in the past 30 days. * patients with a life expectancy less than 3 months. * women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study. * patients on treatment with anticoagulants or who have been on treatment during the week previous to insert the cvc (including prophylaxis with heparin for hepatic veno-occlusive disease). * patients diagnosed with acute leukemia or awaiting a transplant from hematopoietic progenitors during the 90 days of the study.

Keywords: cancer thrombosis catheter bemiparin prophylaxis